DETAILED ACTION
Applicant’s response, filed August 21, 2026, are fully acknowledged by the Examiner. Currently, claims 1-20 are pending with claims 11-20 withdrawn. The following is a complete response to the August 21, 2026 communication.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group I (Claims 1-10) in the reply filed on August 21, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 21, 2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 9, the claim sets forth therein that “the second guidewire is energized using a discrete …”. The Examiner is of the position that such a recitation is method-like language in an apparatus claim that renders the scope of the claim as indefinite. Specifically, it is unclear to one of ordinary skill in the art if infringement of the claim would occur when the second guidewire is specifically energized in the manner set forth in claim 9, or only when a system with a second guidewire capable of being energized as claimed is provided. The Examiner respectfully suggests the use of functional language such as “wherein the second guidewire is configured to be energized using a discrete wattage of power for repeating periods of time” to correct the issue. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Decker et al. (WO 2022/263213 A1).
Regarding claim 1, Decker provides for a magnetically guided re-entry catheter system configured to bypass a chronic total occlusion within an artery, the system comprising:
a catheter (see [0036] providing for “a catheter with a tool” is inserted along a guidewire),
at least one magnet (electromagnet 20),
a first guidewire configured to direct the catheter through the artery (guidewire 12),
a second guidewire comprising a ferromagnetic tip (16 with the magnet 18), wherein the second guidewire is configured to be magnetically attracted to the at least one magnet 18 is configured to be attracted to the electromagnet 20).
Regarding claim 2, Decker provides that the system further comprising at least one electrode, wherein the at least one electrode can be electrically connected or disconnected (electrode for connecting the positive wire 26 to the controller).
Regarding claim 3, Decker provides that the system further comprising a grounding pad, wherein the grounding pad can be electrically connected or disconnected (conductive pad for connecting the negative wire 24 to the controller).
Regarding claim 10, Decker provides for a guide extension system configured to assist in directing the catheter through the artery (the proximal end of the catheter for manipulation by the use so as to advance the catheter as in [0036] along the guidewire).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Decker et al. (WO 2022/263213 A1) as applied to claim 1 above, and further in view of Munger et al. (US Pat. Pub. 2008/0039830 A1).
Regarding claims 4 and 9, while Decker provides for the second guidewire being functionally capable of cutting through tissue as claimed, Decker fails to specifically provide that the cutting is provided by an electrosurgical generator configured to energize the second guidewire. Munger provides for a similar guidewire as that of Decker that is utilized to cutting through tissue. Munger specifically provides for the inclusion of an electrosurgical generator that is configured to energize the second guidewire (generator for providing RF power to the guidewire with the electrode 128 at the tip 124; see at least [0032] describing the application of energy for the passage through tissue). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized an electrically conductive arrangement at the distal tip of the second guidewire of Decker in view of the teaching of Munger to provide for an exemplary manner of crossing through tissue within the body. The Examiner notes that, in view of the combination with Munger and the electrically active second guidewire, the configuration would further provide for such to be capable of energized with a discrete wattage of power for repeated periods of time in view of the disclosed in at least [0032] of Munger.
Regarding claim 8, while Decker provides for the first guidewire being capable of being electrically connected/disconnected (via the connection/disconnection of the source of energy for the electromagnet to the first guidewire), Decker fails to provide that the second guidewire can be electrically connected or disconnected. Munger provides for a similar guidewire as that of Decker that is utilized to cutting through tissue. Munger specifically provides for the inclusion of an electrosurgical generator that can be electrically connected/disconnected to a cutting guidewire (generator for providing RF power to the guidewire with the electrode 128 at the tip 124; see at least [0032] describing the application of energy for the passage through tissue). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized an electrically conductive arrangement at the distal tip of the second guidewire of Decker in view of the teaching of Munger to provide for an exemplary manner of crossing through tissue within the body. The Examiner notes that, in view of the combination with Munger the electrically active second guidewire, the configuration would further provide for the second guidewire to be capable of being electrically connected or disconnected to the RF energy source to provide for the cutting.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Decker et al. (WO 2022/263213 A1) as applied to claim 1 above, and further in view of Eoin et al. (WO 2017/092782 A1).
Regarding claims 5 and 6, while Decker contemplates a magnet as set forth in the rejection of claim 1 above, Decker fails to provide that the at least one magnet is affixed to a distal portion of the catheter per claim 5 or that the system further comprises a capsule affixed to the distal end of the catheter, wherein the capsule is configured to contain or receive the at least one magnet. Eoin provides for an exemplary catheter and guidewire arrangement where the catheter 20 includes a at least one magnet affixed to a distal potion of the catheter such that the catheter includes a capsule affixed to the distal end of the catheter so as to contain/receive the at least one magnet (22 as in lines 7-11 of page 19 providing for the magnet 22 to be formed as an integral part of the catheter shaft 21 where such would require the magnet 22 to be encapsulated within the shaft).
Therefore it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have provided the catheter with the magnet arrangement as the catheter and magnet in claim 1, and then further to utilize the magnet as set forth in each of claims 5 and 6. Such an alternative interpretation where the magnet in claim 1 is formed by the magnet 22 of the catheter of Eoin would result in the catheter to be readily capable of magnetically aligning the distal end of the catheter relative to the magnet guidewire of Decker so as to ensure that the catheter is located at the correct position for treatment within the body.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Decker et al. (WO 2022/263213 A1) as applied to claim 1 above, and further in view of Eskuri (US Pat. Pub. 2013/0267934 A1).
Regarding claim 7, while Decker provides for the second guidewire as in the rejection of claim 1 above, Decker fails to specifically provide for a microcatheter encapsulating the second guidewire. Eskuri provides a similar guidewire arrangement as that of Decker and specifically contemplates for the encapsulating a guidewire within a microcatheter is a well-known and conventional arrangement in the art to provide access within the body of a patient. Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a microcatheter as in Eskuri with the second guidewire of Decker to provide for an exemplary manner of access along the second guidewire after such is advanced within the body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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